The adoption of disposable, or single-use technology (SUT), in biopharmaceutical manufacturing is growing rapidly. SUT offer improved flexibility, reduced risk of contamination and lower costs. Bags made from laminated polymers are widely used as disposable containers for the freezing and storage of bulk drug substance (BDS), but where the properties of the BDS require it to be stored at -196°C, fluoropolymer bottles are the only choice due to their much wider working temperature range. And, while single-use bags were purposely designed for bioprocess manufacturing, the only fluoropolymer bottles available were originally designed for use in the chemical industry. Savillex Purillex® bottles are the first fluoropolymer bottles designed specifically for the bioprocess industry. Manufactured in an ISO Class 7 cleanroom, by a proprietary stretch blow molding process, these bottles provide the lowest level of particulates while the unique design provides superior sealing over extensive temperature ranges.
Purillex bottles are available in PFA and FEP and can be supplied double-bagged and autoclaved ready-to-use (RTU). The latest addition to the Purillex® bottle line is the ETFE version which is unique to Savillex. ETFE, featuring the same cleanliness and low temperature working range as PFA, has the key benefit of being gamma stable. ETFE bottles are supplied double-bagged and gamma sterilized ready-to-use (RTU).
Purillex bottles are the safest choice for storing and shipping bulk drug substance and are complemented by a range of stability testing vials
In addition to the Purillex line of fluoropolymer bottles, our new, state-of-the-art, Single-Use Center of Excellence facility offers an ISO Class 7 cleanroom designed specifically for the assembly of open architecture, single-use systems.